Teva Cited For Promo Suggesting 14-Year Old Schizophrenia Study Shows Clozapine Superiority
This article was originally published in The Pink Sheet Daily
FDA says Teva’s promotional piece misleadingly implies clozapine is superior to olanzapine, risperidone and haloperidol in improving one symptom cluster.
You may also be interested in...
The schizophrenia drug’s previous owner, Azur Pharma, produced a patient brochure that drew a warning letter FDA’s Office of Prescription Drug Promotion.
New proposed rule says a manufacturer’s knowledge of the unapproved use of a product does not alone determine intended use. Former FDA lawyer says rule could set off fireworks over the scope of what the agency considers evidence of off-label use.
Justice Ginsburg wrote two decisions in pharmaceutical related-cases over the past decade, joined the majority in opinions on the scope of patents, and dissented in decisions giving protection to generic manufacturers and speech of pharmaceutical companies. Her death could impact the outcome of cases challenging the Affordable Care Act.